Vacancy expired!
Please note that this is a 1 year contract position. QUALIFICATIONS:Bachelor’s degree in Science with min 2 years of experience at a medical or manufacturing facility; or equivalent combination of education and experience. This position is primarily responsible for testing microplates that are coated with Antigens, formulation and in-process testing of reagents, conjugates and controls for Donor Screening Kit Components according to established procedures or approved protocols. Need to be familiar with multiple testing / formulation labs in Donor Screening Area.Donor Screening Kit for ELISA Test System includes the following seven components that are product-specific: positive control, negative control, conjugate-antibody, antigen-coated microwell plates, specimen diluent, substrate buffer and o-phenylenediamine 2-HCl tablets. This results in common manufacturing sub-process steps that include formulation of multiple bulks and antigen-coated microplate process.
It includes receipt and inspection of incoming raw materials, microplate coating and testing, formulation and in-process testing of reagents, conjugates and controls, filtration and filling of bulks, and release testing followed by kit packaging. Manufactured finished goods are released on acceptable in-process, QA release testing along with concurrent CBER lot release according to set specificationsThe position also supports diverse departments with regards to Donor Screening associated functional needs You will ensure materials are available to meet the production schedule. You will be responsible for training other team members. And, you will be responsible for quality and maintaining the highest standards in compliance within company policies, procedures and all applicable regulations.MAJOR DUTIES AND RESPONSIBILITIES:Perform all manufacturing processes in accordance with GMP’s, SOP’s, TMs, safety rules and production schedule. Assist in the manufacture and qualification of In-House panels. Use current documentation system as required. Troubleshoot operational problems. Works in an environment with ever-changing priorities. Maintains accurate, complete and timely written batch records and documentation. Perform batch record review of documents as needed.Knowledge and understanding of test methods and interpretation of test results.Verify and enter production parameters per SOP and Batch Records.Accurately complete documentation in batch records, logbooks, systems, forms and other GMP documents.Maintain supplies and test reagent inventory.Schedule Lab activities for yourself and team members.Perform ERP transactions to ensure inventory is accurate. Perform cycle counts and special counts in a timely manner. Assure all raw materials are on-hand as needed for manufacturing processes .Participate in group’s compliance efforts regarding safety regulations and requirements including cGMPs, OSHA, Universal Precautions and Product License Agreements.Clean and maintain production areas and equipment according to procedures. Ensure equipment maintenance programs are followed, equipment is calibrated and scheduled preventative maintenance is performed when required.Good understanding of products and processes.Good knowledge of Biology, Chemistry, Biochemistry and Immunology theory and practice.Attention to detail, documentation accurate and neat, must be very organized.Interpersonal skills to include working independently or as a team member.Excellent communication skills, both written and verbal.Applicants must provide their phone number. Reference job number A1227.Vacancy expired!